PACEPORT: Right Ventricular Pressure Waveform Monitoring in Cardiac Surgery

Sponsor

Montreal Heart Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04092855

Collaborator

Edwards Lifesciences (Industry)

112

Enrollment

Location

36.7

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes.

However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. The investigator's primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Dysfunction Right Heart Failure Congestive Heart Failure

Detailed Description

Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. RV dysfunction can occur in a number of clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery.

Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation. However, echocardiographic indices alone are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system. The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension. It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.

Study Design

Study Type:

Observational

Anticipated Enrollment :

112 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Identification and Prediction of Right Ventricular Dysfunction and Failure in Critically Ill Patients: An Observational Non-Interventional Cohort Study

Actual Study Start Date :

Dec 10, 2018

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU [From thermodilution catheter insertion until 2 hours after ICU arrival]
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg.

Secondary Outcome Measures

Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery [From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours.]
Difficult separation from cardiopulmonary bypass: instability requiring at least two different types of pharmacological agents (i.e., inotropes ± vasopressors ± inhaled agents) Complex separation from cardiopulmonary bypass: Hemodynamic instability requiring return on cardiopulmonary bypass or addition of mechanical support (intra-aortic balloon pump or extra-corporeal membrane oxygenator)
Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery [Up to 28 days or until hospital discharge]
TPOD is a continuous variable representative of the burden of care and morbidity during the first 28 days following cardiac surgery and was chosen to circumvent issues arising for using other clinical endpoint such as ICU length of stay
Incidence of deaths during hospitalisation [Up to 30 days or until hospital discharge]
Death from any cause
Incidence of acute kidney injury (AKI) [Up to 28 days or until hospital discharge]
Acute kidney injury (AKI) according to KDIGO serum creatinine criteria: Stage 1: ≥50% or 27 umol/L increases in serum creatinine, Stage 2: ≥100% increase in serum creatinine, Stage 3 ≥200% increase in serum creatinine or an increase to a level of ≥254 umol/L or dialysis initiation.
Incidence of major bleeding [Up to 28 days or until hospital discharge]
Major bleeding is defined by the Bleeding Academic Research Consortium (BARC) as one of the following: Perioperative intracranial bleeding within 48h Reoperation after closure of sternotomy for the purpose of controlling bleeding Transfusion of ≥5 units of whole blood of packed red blood cells within a 48 hours period Chest tube output ≥2L within a 24 hours period
Incidence of surgical reintervention for any reasons [Up to 28 days or until hospital discharge]
Re-operation after the initial surgery for any cause
Incidence of deep sternal wound infection or mediastinitis [Up to 28 days or until hospital discharge]
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician
Incidence of delirium [Up to 28 days or until hospital discharge]
Delirium is defined as an intensive care delirium screening checklist (ICDSC) score(18) of ≥4 in the week following surgery or positive result for the Confusion Assessment Method for the ICU (CAM-ICU).
Incidence of stroke [Up to 28 days or until hospital discharge]
Central neurologic deficit persisting longer than 72 hours
Total duration of ICU stay in hours [Up to 28 days or until hospital discharge]
Number of hours passed in the ICU
Duration of vasopressor requirements (in hours) [Up to 28 days or until hospital discharge]
Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine.
Duration of hospital stay (in days) [Up to 28 days or until hospital discharge]
Number of days hospitalized from the day of surgery to discharge
Duration of mechanical ventilation (in hours) [Up to 28 days or until hospital discharge]
A duration of >24 hours will be considered prolonged ventilation requirements.
Incidence of major morbidity or mortality [Up to 28 days or until hospital discharge]
Including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.
Right ventricular ejection fraction [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
Right ventricular fractional area change [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
Right ventricular strain [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
Tricuspid annular plane systolic excursion [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
Right ventricular performance index [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
Portal flow pulsatility fraction [From arrival to the operating room until 2 hours after ICU arrival]
Defined as the difference between the maximal and the minimal velocity during the cardiac cycle divided by the maximal velocity
Right ventricular stroke work index [From arrival to the operating room until 2 hours after ICU arrival]
0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)
Relative pulmonary pressure [From arrival to the operating room until 2 hours after ICU arrival]
The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure
Right ventricular function index [From arrival to the operating room until 2 hours after ICU arrival]
Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time
Pulmonary artery pulsatility index (PAPi) [From arrival to the operating room until 2 hours after ICU arrival]
Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure]
Compliance of the pulmonary artery (CPA) [From arrival to the operating room until 2 hours after ICU arrival]
Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)
Pulsatility of femoral venous flow [From arrival to the operating room until 2 hours after ICU arrival]
Velocity variations of blood flow in the femoral vein during the cardiac cycle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

-Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.

Exclusion Criteria:

Emergency surgery or inability to obtain consent
Concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8

Sponsors and Collaborators

Montreal Heart Institute
Edwards Lifesciences

Investigators

Principal Investigator: Andre Denault, MD,PhD, Montreal Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Andre Denault, Principal Investigator, Montreal Heart Institute

ClinicalTrials.gov Identifier:

NCT04092855

Other Study ID Numbers:

2019-2527

First Posted:

Sep 17, 2019

Last Update Posted:

Nov 13, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andre Denault, Principal Investigator, Montreal Heart Institute

Right Ventricular Pressure Waveform

Additional relevant MeSH terms:

Heart Failure

Ventricular Dysfunction

Ventricular Dysfunction, Right

Study Results

No Results Posted as of Nov 13, 2020